Renin-guided Hemodynamic Management in Patients With Shock
NCT05898126 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2025-08-06
Summary
Shock is a major risk factor for mortality among patients admitted to intensive care units (ICUs). Since various hemodynamic strategies uniformly delivered to patients with shock have failed to improve clinically relevant outcomes, individualized approaches for shock supported by robust evidence are required. This study will be a prospective, multicenter, parallel-group, single-blind, randomized controlled trial. The investigators will randomly assign 800 critically ill patients requiring norepinephrine infusion to the renin-guided or usual care groups. The investigators hypothesize that renin-guided hemodynamic management, compared to usual care, can reduce a composite of mortality and acute kidney injury (AKI) progression in patients requiring vasopressor support.
Conditions
- Shock
Interventions
- PROCEDURE
-
Renin-guided hemodynamic management
If normalization of renin levels is achieved (values within the normal laboratory range), we will continue with usual care according to local protocols.
- PROCEDURE
-
Usual care
Standard of care
Sponsors & Collaborators
-
Università Vita-Salute San Raffaele
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-27
- Primary Completion
- 2027-04-28
- Completion
- 2027-07-28
Countries
- Croatia
- Italy
Study Locations
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